1. Field of the Invention
The invention is generally related to non-invasive fluid collection apparatus and is specifically directed to a female urine collection device adapted for use in confined environments such as fighter jet cockpits or weightless environments in space and/or for use with invalid or semi-invalid patients.
2. Discussion of the Prior Art
Collection of urine in weightless environments has long been a problem on extended space flights. The problem is particularly complicated for female astronauts. Over the last twenty years, a number of devices have been designed and tested, but to date, all have been rejected because of discomfort in use, leakage and health risks, drawbacks that are particularly unsuitable for extended space flight. In addition, such devices are typically difficult to secure in place, which further aggravates the above mentioned drawbacks. Examples of devices which have proven to be unacceptable are manufactured by Hollister, Inc., Sherwood Medical Company and Rochester Medical. ITW Diamed Division also offered a Misstique External Urinary Collection System at one time. A product sold under the name FemFit has also been tested. The FemFit was rejected because of discomfort. While the Hollister and Misstique devices were more comfortable, they are semipermanent devices which must be fitted internally on the astronaut for the duration of the flight.
More recently, devices have been developed which include a rabbit ear type construction to be inserted into the vagina, with a cup placed over the urinary meatus, to be worn during the entire flight. This prior art device has been found to be undesirable because it is difficult to insert, is often painful to wear, and often leaks due to the collapsible tendency of the cup. In 1989, Merz, et al received U.S. Pat. No. 4,889,532, entitled: FEMALE URINARY INCONTINENCE DEVICE WITH A FORWARDLY-DIRECTED DISCHARGE PASSAGE AND SUPPORT SURFACE PORTIONS. The device is designed to be used primarily while seated, and incorporated a large pad attached to a periurinary meatus cup with a vaginally receptive urine deflective extension. In a weightless environment, the deflective extension actually drives urine into the vagina, causing discomfort, leakage and possible infection. The device is particularly ill-suited for extended space flight use. In a normal gravitational environment, leakage is a serious problem, since fluids tend to collect on the pad and then spill once the pad is removed. However, under weightless conditions, even a slight leak, which may be tolerable in a normal environment, is completely unacceptable. Furthermore, while a number of devices, such as belts and undergarments, have been utilized in attempts to secure these urine collection cups in place, nothing in the prior art has heretofore been found to be acceptable.
Although the above mentioned problems are most acute with respect to space flight, similar problems have been observed in urine collection devices utilized in other environments, such as hospitals or nursing homes, where such devices may be utilized for persons unable to function normally without assistance.
The subject invention is directed to a urine collection device for use by female astronauts while in a weightless environment. The device is also ideally suited for use in cases where a female patient is confined to a recumbent position. The device of the present invention permits collection of urine, either for disposal or for collection of specimens and samples, without leakage using a non-invasive procedure.
The preferred embodiment of the invention utilizes a malleable ring, preferably of a formable metal or rubber, that can be formed or manipulated to fit by the user or the care provider. A collection receptacle is attached to the ring. In one preferred embodiment, the receptacle is an external catheter and resembles a collapsible bag or cup with an elongated, reduced neck portion secured to the ring. In another embodiment, the receptacle is a cup integrally formed with the ring. In use, the ring is held on the palm side of the hand with the receptacle extending through the gap between the index and forefingers, such that the receptacle and any attached fluid capture bag are located on the back side of the hand. With the bag away from the body, the ring is placed against the tissue around the urethral meatus in a position such that it is in communication with the urinary meatus opening completely surrounding it. The ring is shaped to permit a good fit. The ring is held in position by the two fingers, with the palm of the hand toward and against the genital region and the fingers positioned to point in a posterior direction. The seal is formed by pressing the ring into the tissue around the urinary meatus. This achieves a good seal in the anterior portion of the tissue around the urethral meatus because of the firmness of the tissue in that area. If necessary, a good seal may be assured in the posterior portion of the ring by pressing the lower part of the ring slightly inside the vaginal opening or entrance and against the anterior wall thereof. When properly positioned, the ring should fit between the bones of the pelvis. The user then voids through the ring and into the receptacle which is in fluid communication via a tube with a urine capture device such as a bag or vacuum system. The receptacle may be sealed at the tube by clamping. In some applications, particularly in a weightless environment, the receptacle may be squeezed by the fingers prior to clamping to assure that all of the voided urine is forced into the bag.
Where desired, a probe may be provided on the lower portion of the ring to assure proper positioning of the ring relative to the urinary meatus and the vagina. This is particularly useful when a care giver is using the device with an invalid patient. In one embodiment, such probe may be integrally formed with the ring. In another embodiment, such probe may be integrally formed with the ring and the receptacle.
The device is particularly well suited for use in a weightless environment where gravity cannot be used to assist in the flow of the voided liquid. All of the void is directed into the neck of the receptacle which can be squeezed, as necessary, to assure all of the liquid is driven into a capture bag attached to the device. The device virtually eliminates leakage since it forms a good seal around the urinary meatus opening in a unique and non-invasive manner.
It is, therefore, an object and feature of the invention to provide a convenient, easy to use device for collecting voided liquids in a weightless environment by a female astronaut.
It is also an important object and feature of the invention to provide a urine collection device which may be used by patients while in either a standing, sitting or recumbent position for collection of specimens or for disposal.
It is another object and feature of the invention to provide a female urine collection device that permits collection of the voided liquid in a non-invasive procedure.
It is a further object and feature of the subject invention to provide a urine collection device which is easy to use and may be utilized with minimum training either by the user or by a care giver.
It is an additional object and feature of the invention to provide a female urine collection device that is of simple design and is inexpensive to manufacture, permitting mass manufacture of the units in a disposable configuration.
Other objects and features of the invention will be readily apparent from the drawings and following detailed description.